Endoscopic Intragastric Balloon Placement for Weight Loss in Liver Transplant Waitlist Candidates

Stopped early · Not applicable

Conditions studied: Obesity, Liver Cirrhosis

In brief

The purpose of this study is to determine whether the Orbera Intragastric Balloon is a safe and effective means for weight loss and improved metabolic disease in patients with cirrhosis requiring liver transplantation.

Key facts

Study ID

NCT02556138

Run by

Mayo Clinic

People needed

8

Starts

2015-09-01

Expected to finish

2016-11-03

Last updated by the study team

2018-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults with end-stage liver disease who are listed for liver transplant
• Have failed the non-invasive approach to weight loss to be actively listed for transplant (requiring 2 clinical return visits without weight loss of >5 kg)
• Body Mass Index (BMI) >35
• Negative pregnancy test for females who are able to get pregnant and are of child-bearing age

You may not qualify if…

• A previous history of gastric or bariatric surgery
• Current or recent (within 6 months) gastric or duodenal ulcers
• Moderate to severe Portal hypertension defined as portal gastropathy graded as >= to moderate/severe, gastric varices, or esophageal varices graded > = moderate/large (Patients with varices which have been obliterated may be included).
• Calculated Model of End-stage Liver Disease (MELD) score >25 or childs score >10
• The presence of more than one gastric balloon at the same time
• Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
• A large hiatal hernia or >5 cm hernia or ≤5 cm with associated severe or intractable gastro-esophageal reflux symptoms.
• A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope.
• Achalasia or any other severe motility disorder that may pose a safety risk during removal of the device.
• Gastric mass
• Severe coagulopathy
• Patients who are known to have or suspected to have an allergic reaction to materials contained in ORBERA.
• Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 6 months.
• Alcoholism or drug addiction
• Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant
• Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
• Patients receiving aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants, not under medical supervision.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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